Anoro Ellipta Use In Pregnancy & Lactation

Fertility: There are no data on the effects of Umeclidinium+ Vilanterol (Anoro Ellipta) on human fertility. Animal studies indicate no effects of umeclidinium or vilanterol on fertility (see Pharmacology: Toxicology: Non-Clinical information under Actions).
Pregnancy: There are no or limited amount of data from the use of Umeclidinium+ Vilanterol (Anoro Ellipta) in pregnant women. Studies in animals have shown reproductive toxicity after inhaled administration of vilanterol (see Pharmacology: Toxicology: Non-Clinical information under Actions). Umeclidinium+ Vilanterol (Anoro Ellipta) should be used during pregnancy only if the expected benefit to the mother justifies the potential risk to the foetus.
Lactation: It is unknown whether umeclidinium or vilanterol are excreted in human milk. However, other beta₂-agonists are detected in human milk. A risk to breastfed newborns/infants cannot be excluded.
A decision must be made whether to discontinue breastfeeding or to discontinue Umeclidinium+ Vilanterol (Anoro Ellipta) therapy taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.